ClinicaliQ Trial Snapshot
- LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07288398.
- What is being tested: Oral levosimendan efficacy and safety in patients with pulmonary hypertension combined with heart failure with preserved ejection fraction (PH-HFpEF), with exercise limitation as the primary outcome measure.
- Patient eligibility overview: Adults with confirmed PH-HFpEF diagnosis presenting with exercise limitation; specific haemodynamic and functional criteria typically required for inclusion.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
Eligibility Snapshot
- : 1. Men or women, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A qualifying 6-MWD 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period 8. Requirements related to child bearing potential, contraception, and egg/sperm donation)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.